FDA 510(k) Application Details - K243580

Device Classification Name	Syringe, Piston   More FDA Info for this Device
510(K) Number	K243580
Device Name	Syringe, Piston
Applicant	SurGenTec, LLC. 911 Clint More Road Boca Raton, FL 33487 US Other 510(k) Applications for this Company
Contact	Jason Hershman Other 510(k) Applications for this Contact
Regulation Number	880.5860   More FDA Info for this Regulation Number
Classification Product Code	FMF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/19/2024
Decision Date	02/05/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review